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FDA-HHS Cannabis-Related Falsehoods Given Legal Standing .....

It comes as no big surprise to prudent observers ..... When Federal Regulatory agencies are given a "free-pass" to allege false-information as fact ..... Partisan rulings follow on a federal level ..... trickling down to state governments wanting to protect their citizens from over-zealous regulatory abuses .....

"The HHS concluded that the currently available data and information on marijuana is not sufficient to allow scientific scrutiny of the chemistry, pharmacology, toxicology, and effectiveness."

Apparently ..... The FDA has alleged that CBD's can no longer be considered as dietary supplements since they are being scientifically studied as potential pharmaceutical protocols ..... known as IND's ..... "Investigational New Drugs" ..... While the FDA admits publicly ..... CBD's are being studied for potential medical purposes ..... yet they cemented the recent DEA ruling by asserting Cannabis has no "known" medical value ..... Nice job of gridlock fellas !!! ..... One assumes the argument technically hinges on their tactical use of the term "known" ..... since it would be premature to ascribe efficacy to a drug in the midst of IND trails ..... though it looks like DEA ..... FDA ..... HHS ..... along with whomever else might be linked into the regulatory chain of obfuscation and denial ..... have most certainly betrayed our nation from an ethical and moral perspective ..... while the general populace cries for medical-cannabis relief seeking change ..... From my perspective ..... A careful reading and rendering of facts pokes a multitude of holes through the presumptive legal justifications of ALL Federal regulatory agencies ..... Yet they seemingly win the day !!! .....

How America's Federal Regulatory Agencies manage to stretch the truth any direction desired ..... in service to their "gainful-special-interest" policies leaves one dumbfounded and discouraged .... Perhaps ..... a logical consequence ..... due to ..... " A life of luxury lacking accountability ? " .....

Hopefully ..... the Industry will prevail in its ongoing struggle to protect CBD's .....


FDA’s Latest CBD Warning Letters Cite Health Claims, Drug Applications

February 19, 2016

By Michael Crane ..... "Nutritional Outlook Magazine" .....

The debate over hemp CBD’s legal status continues after FDA sent eight warning letters to manufacturers of CBD dietary supplement and food products earlier this month. The warning letters cite impermissible health claims used to market the products, as well as CBD’s invalid status as a dietary ingredient due to its presence in two drug applications currently under consideration.

CBD, short for cannabidiol, is a non-psychoactive variety of Cannabis sativa and a relative of tetrahydrocannabinol (THC). It has become increasingly prevalent in food and dietary supplement products, although FDA has not officially recognized CBD as a legal dietary ingredient.

On February 4, FDA sent warning letters to eight companies marketing CBD foods and dietary supplements, partially on the basis of impermissible medical claims used in marketing materials. These include suggestions that CBD may be used to reduce symptoms of schizophrenia, rheumatoid arthritis, diabetes, cancer, multiple sclerosis, and more.

These claims are not allowed on any dietary supplements, according to FDA, because they address “one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.”

But CBD’s “[exclusion] from the dietary supplement definition” appears to be an even more prominent concern than improper health claims in this new batch of warning letters. That’s because CBD is included in two Investigational New Drug (IND) applications currently under investigation from GW Pharmaceuticals for its Sativex and Epidiolex products.

While some of FDA’s past warning letters to companies marketing CBD supplements have focused solely on improper health claims and sidestepped the legality of CBD as a dietary ingredient, it’s notable that FDA is now making CBD’s “excluded” status as a dietary supplement a major point in its latest warning letters.

Citing section 201(ff)(3)(B)(ii) of the Food, Drug, and Cosmetic Act, FDA explains that “if an article (such as CBD) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”

FDA notes that an exception could be made if CBD was “marketed as” a dietary supplement before the new drug investigations were authorized, but that “based on available evidence, FDA has concluded that this is not the case for CBD.”

HIA Response

In a statement issued today, the Hemp Industries Association (HIA; Summerland, CA) disputed FDA’s characterization of CBD’s history in supplement products, claiming “legal hemp products containing CBD were marketed as foods and dietary supplements long before cannabidiol formulations were submitted to the FDA for testing as a ‘new drug.’”

However, on the other point in FDA’s warning letters—impermissible medical claims in the marketing materials for these products—HIA agrees that CBD food and supplement products should not be using these claims.

“Though none of the companies in receipt of these warning letters are current or former HIA members, the HIA urges these CBD product manufacturers to revise their product labeling and marketing such that no medical claims are made,” according to HIA’s announcement.

Read more:

Will Hemp CBD Be a Drug or a Dietary Supplement Ingredient?

Will FDA Grant Hemp GRAS, NDI Status If U.S. Hemp Growing Is Legalized?

Michael Crane
Associate Editor
Nutritional Outlook Magazine
[e-mail]


http://www.nutritionaloutlook.com/herbs-botanicals/fda%E2%80%99s-latest-cbd-warning-letters-cite-health-claims-drug-applications

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